1. Field of the Invention
This invention relates generally to the field of devices for the treatment of respiratory conditions in which nasal dilation is performed. In particular, this invention relates to nasal dilators with the adaptation of providing electrical stimulation.
2. Background Description
Normal respiration requires that air passages remain open. Blockage of the nasal passages, for example from a deviated septum, or allergic swelling of tissues, may result in reduction in oxygen delivery to the brain and/or heart and may be part of the syndrome of snoring and/or obstructive sleep apnea (OSA). Nasal obstruction may lead to sustained mouth breathing and possible lung irritation.
Anatomically, the vestibule, which is immediately above the entrance to the nostril, tapers inwardly to a narrowed neck-like region called the ostium internum, above which the nasal passages widen out again. Nasal obstructions commonly occur at the ostium, wherein the lateral wall (i.e., the outer wall tissue of the nasal passage) draws in during the process of inhalation acting as a “check valve” blocking air flow.
As an alternative to surgery, internal and external nasal dilators for aiding breathing through the nose have been devised. These devices are well known in the prior art; for example, U.S. Pat. No. 576,441 to Farmer issued in 1897 is an early internal nasal expander and U.S. Pat. No. 1,043,924 to Gottlieb issued in 1912 is an early external nasal dilator. Whereas, U.S. Pat. No. 4,414,977 issued in 1983 to Rezakhany, and U.S. Pat. No. 5,533,499 issued in 1994 to Johnson are more modern concepts of nasal dilators.
A nasal dilator may contact the nasal septum, such as U.S. Pat. No. 5,713,833 to Miligan issued in 1998. Nasal dilators have been combined with medication, as in U.S. Pat. No. 5,706,800 to Cronk issued in 1997 and with heat, as in U.S. Pat. No. 5,890,486 to Mitra issued in 1998. Nasal dilators have been utilized in eyeglasses as in U.S. Pat. No. 6,006,746 to Karell in 1998 and in surgical masks as in U.S. Pat. No. 6,336,456 to Ruben in 2002.
The instant invention combines nasal dilators with electrical stimulation. Electrical stimulation without surgically implanting of an electrode is called transcutaneous electrical nerve stimulation (TENS), also called surface electrical stimulation or electro-acupuncture. A simple TENS unit is a battery operated neuromusclular stimulator operationally connected to electrodes in contact with a body surface. An example of a TENS unit is U.S. Pat. No. 4,084,595 issued in 1978 to Miller having capability to control pulse amplitude, rate, and width. An example of a micro-miniature surface stimulator is U.S. Pat. No. 6,961,622 issued in 2005 to Gilbert is utilized for electro-acupuncture.
In Traditional Chinese Medicine, the meridians are the channels through which Chi (the body's vital Life force) flows. Traditionally, points in the human body (acupuncture points) on meridians were reached by piercing the body with needles. By stimulating with needles or electro-acupuncture or TENS, one can effect changes in the local area, as well as distal parts of the body and its organs. Stimulating the skin or mucous membranes using electrical energy, causes nervous impulses which eventually travel to the brain. TENS for pain control has been utilized in medicine for years. Stimulating certain nerves, e.g. the vagus, may treat emotional conditions such as depression or, e.g. the eigth cranial nerve for schizophrenia. Stimulation of airway muscles and nerves has been used for treatment of obstructive sleep apnea (OSA). Nerve stimulation has been utilized to open airways, and may reduce nasal congestion with trigeminal nerve stimulation. Electro-acupuncture has been utilized locally at acupuncture points e.g. Li20 and Gv26 to help reduce nasal congestion. Nasal dilators may also contact the nasal septum region wherein at least one electrode may be utilized for stimulation of this region.
The following are examples of prior art which may be useful in the understanding of the utility of the instant invention:    U.S. Pat. No. 6,238,411 to Thorner entitled “INTERNAL NASAL DILATOR” is described and the entire disclosure of which is incorporated herein by reference.    U.S. Pat. No. 6,453,901 to Ierulli entitled “NASAL DILATOR AND METHOD OF MAKING SAME” is described and the entire disclosure of which is incorporated herein by reference.    U.S. Pat. No. 7,055,523 to Brown entitled “INTERNAL NASAL DILATOR AND DELIVERY MECHANISM” is described and the entire disclosure of which is incorporated herein by reference.    U.S. Pat. No. 5,476,091 to Johnson entitled “DILATOR FOR ANATOMICAL OUTER WALL TISSUES WHICH IS ADHESIVELY MOUNTED” is described and the entire disclosure of which is incorporated herein by reference.    U.S. Pat. No. 6,080,179 to Gould entitled “RESILIENTLY RETRACTING EXTERNAL NASAL DILATOR” is described and the entire disclosure of which is incorporated herein by reference.    U.S. Pat. No. 6,244,265 to Cronk entitled “ADHESIVELY APPLIED EXTERNAL NASAL STRIPS AND DILATORS CONTAINING MEDICATIONS AND FRAGRANCES” is described and the entire disclosure of which is incorporated herein by reference.    U.S. Pat. No. 5,890,486 to Mitra entitled “THERMAL NASAL DILATOR AND METHOD FOR THE RELIEF OF . . . ” is described and the entire disclosure of which is incorporated herein by reference.    U.S. Pat. No. 4,989,605 to Rossen entitled “TRANSCUTANEOUS ELECTRIC NERVE STIMULATION (TENS) DEVICE” is described and the entire disclosure of which is incorporated herein by reference.    U.S. Pat. No. 6,961,622 to Gilbert entitled “DEVICE FOR SURFACE STIMULATION OF ACUPUNCTURE POINTS” is described and the entire disclosure of which is incorporated herein by reference.